findmyKOL
Clinical trialNCT03634072TerminatedInterventional

Pediatric REPlAcement of the PulmonaRy ValvE in Tetralogy of Fallot -

SponsorChildren's Hospital of PhiladelphiaEnrollment1Tetralogy of Fallot
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Tetralogy of Fallot (TOF) is the most common cyanotic congenital heart defect with the vast majority of survivors of corrective surgery left with some degree of right ventricular (RV) volume overload due to pulmonary regurgitation (PR) which cause RV enlargement with right heart failure, diminished biventricular function, ventricular arrhythmia, sudden death and decreased exercise performance over time. Pulmonary valve replacement (PVR) has been thought to ameliorate these complications but the timing of replacement has yet to be determined with equipoise at the moment in this decision making process. As nearly all studies in this regard are retrospective with much less data in pediatric TOF than adults, this pilot trial sets the stage to create a prospective randomized trial in the teenage years.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

6 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Children'S National Medical Center

    Washington D.C., District of Columbia, United States

  • Children'S Healthcare of Atlanta

    Atlanta, Georgia, United States

  • Lurie Children'S Hospital of Chicago

    Chicago, Illinois, United States

  • Northwestern University

    Chicago, Illinois, United States

  • Cincinnati Children'S Hosptial Medical Center

    Cincinnati, Ohio, United States

  • the Childrens Hospital of Philadelphia

    Philadelphia, Pennsylvania, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study — it may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
6 Jul 2018
Primary completion
16 Jan 2021
Completion
16 Jan 2021
Last update posted
6 Oct 2023
Registered enrollment
1
Registry id
NCT03634072

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.